Rules for Participation - CAIXAIMPULSE CONSOLIDATE 2019

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Rules for Participation - CAIXAIMPULSE CONSOLIDATE 2019
Rules for
Participation
CAIXAIMPULSE CONSOLIDATE
          2019

              Rules of Participation CAIXAIMPULSE CONSOLIDATE   1
Rules for Participation - CAIXAIMPULSE CONSOLIDATE 2019
Rules for Participation

Index
                                                                                                                                                             Page

Executive Summary..................................................................................................................................3
Preamble.........................................................................................................................................................4
A. RULES FOR PARTICIPATION............................................................................................................4
     1. Aims.........................................................................................................................................................4
     2. CaixaImpulse Consolidate general framework...................................................................5
     3. General Calendar...............................................................................................................................5
     4. Eligibility Criteria and Requirements........................................................................................6
         Projects...................................................................................................................................................6
         Beneficiary............................................................................................................................................7
         Project Leader.....................................................................................................................................7
     5. Application Process..........................................................................................................................8
     6. Evaluation Process and Criteria..................................................................................................9
         Pre-selection process......................................................................................................................9
         Selection process............................................................................................................................ 10
     7. Support to Projects..........................................................................................................................11
         Financial resources.........................................................................................................................11
         Non-financial.....................................................................................................................................11
     8. Follow-up of Projects................................................................................................................... 12
B. GENERAL ANNEX.................................................................................................................................13
     9. IP Rights, Protection and Maintenance of the Assets.....................................................13
     10. Exploitation......................................................................................................................................14
     11. Reimbursement..............................................................................................................................14
     12. Subscription Right........................................................................................................................ 15
     13. Other Obligations..........................................................................................................................16
     14. Representations and Warranties.............................................................................................17
     15. Breach and Liability..................................................................................................................... 18
     16. Duration............................................................................................................................................ 18
     17. Confidentiality.................................................................................................................................19
     18. Data Protection.............................................................................................................................20
     19. Publicity and Dissemination.................................................................................................... 21
     20. Miscellaneous................................................................................................................................ 22
     21. Acceptance of conditions........................................................................................................ 22
Additional Information........................................................................................................................ 23
Glossary........................................................................................................................................................ 23
Executive
Summary

The ‘‘la Caixa’’ Banking Foundation (hereinafter, “LCBF”) launched its Caix-
aImpulse Programme in 2015. Its first initiative, the CaixaImpulse Call, has
supported leading biomedical research Projects and researchers boost
their innovation potential through valorisation and training actions. Con-
tinuing with its commitment to help the results from groundbreaking re-
search meet societal needs, LCBF is extending its CaixaImpulse Funding
Scheme in response to existing needs in the biomedicine innovation eco-
system.

To this end, the CaixaImpulse Consolidate Call (hereinafter, the “Call”) is
born as a new line of the CaixaImpulse programme with Caixa Capital Risc
as a strategic collaborator. The CaixaImpulse Consolidate Call wishes to
support society-relevant Life Sciences Projects that have a clear roadmap
to commercialisation, that include a robust ongoing valorisation plan or
valorisation activities, and are at a stage of development closer to the mar-
ket. This implies a Technology Readiness Level (TRL) of 4 or greater (in con-
trast to the TRL 1 to 4 expected for Projects applying to the CaixaImpulse
Call). This Call will offer financial and non-financial support to bring the
Assets to a stage of investment readiness.

The Call will consider applications for Projects led by Spanish and Por-
tuguese public or non-profit legal entities (universities, research centres,
hospitals) that own or co-own the Assets resulting from the research ac-
tivity.

In order to diligently respond to a Project’s needs, the Call will be perma-
nently open (with a maximum of 3 cut-offs per year). The evaluation pro-
cess will be comprised of two steps. (1) The application is initiated with a
letter of intent; (2) Pre-selected applications will then be invited to submit
a full proposal that will undergo a deeper evaluation process concerning
the following criteria: (a) Implementation feasibility, (b) Appropriate devel-
opment roadmap, (c) Transfer potential of the Asset, and (d) Social Impact
and Responsible Innovation.

The Call will provide financial support of up to EUR 300,000 for a maxi-
mum of 24 months. Once the Projects achieve specific key performance
indicators (KPIs), financial support will be reimbursed to LCBF to ensure the
sustainability of the programme. In addition, the non-financial and ad-hoc
needs of each Project will be considered.

                                      Rules of Participation CAIXAIMPULSE CONSOLIDATE   3
Preamble
    The “la Caixa” Banking Foundation is supporting the Iberian biomedical research eco-
    system through a range of grants and funding programmes. Moreover, LCBF’s current
    Strategic Plan reflects the firm commitment to the translation of research results into
    society as either new products or new companies.

    Currently, many research Projects are unable to successfully go through the so-called
    “Valley of Death” of the innovation process. During the journey that a technological or
    highly innovative concept must follow until it reaches the market, there is a strict gap left
    by the availability of early-phase (mainly public grants) and late-phase (mainly private
    investment) financing resources. This is a high-risk stage in which many entrepreneurs
    lack enough financing to continue advancing their Projects.

    In order to respond to this need, the CaixaImpulse Programme was created in 2015.
    Currently, it is articulated into two schemes, CaixaImpulse Validate and CaixaImpulse
    Consolidate, which aim to provide support to different stages of biomedical knowl-
    edge and the technology transfer process, from research centres to the market, hence
    contributing to the progress of the well-being of people and society.

    A. Rules for Participation
1   Aims

    1.1. With CaixaImpulse Consolidate, LCBF aims to increase the capacity of Projects to
    successfully advance the development of the Asset into commercialisation with the ulti-
    mate aim of providing innovative solutions for health through:

    »» Facilitating technologies with very high potential to reach market and respond to so-
       cietal needs.
    »» Ensuring that researchers leading groundbreaking Projects can successfully achieve
       their entrepreneurial goals.
    »» Strengthening innovation that is society-oriented in the Iberian biomedical research
       ecosystem.
    »» Triggering a cultural change in the research ecosystem that fosters license agreements
       with existing companies and the creation of new health-based companies.

    1.2. Specifically, the Call seeks to support Projects from public or non-profit legal entities
    in their development of results from scientific research (the “Assets”) into further trans-
    ferability and/or commercialisation stages in which they are able to attract commercial
    investment (the “Projects”). Therefore, selected Projects will be supported according to
    their specific necessities, nature, and maturity stage in order to achieve the:

    »» Completion or execution of valorisation actions through a defined point-of-value in
       the development plan, including prototyping or testing with end users;

                                                   Rules of Participation CAIXAIMPULSE CONSOLIDATE   4
»» Design and/or completion of a business plan;
    »» Design of strategies to access main stakeholders (end users, buyers, distributors, etc.);
    »» Establishment of a plan to make the product, technology, or service attractive for in-
       vestors and potential licensees in the biomedical sector.

2   CaixaImpulse Consolidate general framework

    WHAT?
    LCBF will fund excellent Projects of proven social relevance and with groundbreaking
    innovation potential for the creation of services or products in the area of Life, Medical, and
    Health Sciences.

    WHO?                   HOW?                       WHEN?                    WHY?
    Public or non-profit   The programme offers       The Call will be         To drive the To drive
    entities based in      financial support of       permanently open         the transformation
    Spain or Portugal      up to EUR 300,000          for applications and     of scientific
    that own the assets    for a maximum of 24        a maximum of three       knowledge into
    resulting from         months, as well as         cut-offs per year        value for society.
    research activity.     ad-hoc non-financial       will be established
                           support, reducing          for the review and
                           existing barriers and      selection of Projects.
                           facilitating access
                           to training, existing
                           networks, and key
                           expertise.

    Participating in the Call entails the full acceptance of these Rules for Participation, their
    interpretation lying within the corresponding jury during each stage of the Call.

3   General calendar

    3.1. Submission of Projects will be accepted all year round.

    3.2. Cut-off moments will be defined based on the volume of applications received and
         will be notified accordingly. A maximum of three cut-offs per year for the review and
         selection of proposals will be announced.

    3.3. The evaluation process will consist of two different stages: 1) The Pre-selection of
         applications based on a Letter of Intent; and 2) The Selection of proposals based
         on a full proposal submitted by pre-selected candidates as described in Clause 5.5
         (Full Proposal). Pre-selected Projects will be decided upon within approximately
         one month after each cut-off, and selected Projects will be announced within a
         maximum of three months after the cut-off.

                                                    Rules of Participation CAIXAIMPULSE CONSOLIDATE   5
3.4. To provide equal opportunities for all projects applying at any time of the year, atten-
         tion will be put into the homogeneous distribution of the yearly budget allocated for
         this call throughout that year’s cut-offs. However, the final total amount assigned in
         each cut-off will depend ultimately on the quality of the projects applying as a result
         of the evaluation process.

    3.5. LCBF holds the right to modify the scheduling of the Call due to logistical require-
         ments.

4   Eligibility Criteria and Requirements

    Projects
    4.1. Eligible Projects have to fall into the scientific area of Life, Medical, and Health Sciences:
        »» Life Sciences: Biomathematics, Cell Biology, Human Biology, Biochemistry and
           Molecular Biology, Human Physiology, Genetics, Immunology, Microbiology, and
           Neurosciences.
        »» Medical and Health Sciences: Clinical Sciences, Epidemiology, Medical Specialities,
           Nutritional Sciences, Pathology, Pharmacodynamics, Pharmacology, Preventive
           Medicine, Psychiatry, Public Health, Surgery, and Toxicology.

    4.2. Within the scientific areas defined above, the Assets may belong to one of the fol-
         lowing business areas:
        »» Pharmaceuticals and Medical Biotechnology
        »» Medical Technologies (medical devices and diagnostics)
        »» Digital Health

    4.3. The Call is aimed at research Projects in a mature stage of transferability to the
         market, (e.g., those that may be deemed to have achieved a Technology Readiness
         Level (TRL) equal to or greater than 4 as defined by the European Commission).
         Therefore, only Projects that have already performed significant valorisation ac-
         tivities for the research underlying the Asset will be considered eligible.

    4.4. Assets must have IP registration or any other proven protection strategy, includ-
         ing the application of measures to protect trade secrets.

    4.5. Projects must seek a clear social impact and answer an existing societal medical
         need. Projects that do not define a relevant potential social impact are not eligible.

    4.6. Projects must have a clear focus on innovation: Projects are expected to develop
         a roadmap for the successful transfer of the Asset to the market (Development
         Roadmap), with specific relevant milestones to advance on this path in the context
         of the grant. It is required that the teams clearly identify the appropriate valorisation
         actions and human resources that will lead to that purpose.

    4.7. Projects that evaluate the efficacy or safety of products, therapies, medical devices,
         or diagnostic systems needed for the regulatory approval of the asset are eligible.

    4.8. Projects that have not participated in the CaixaImpulse Programme are eligible to
         participate in CaixaImpulse Consolidate provided they meet the eligibility require-
         ments and are at the appropriate TRL stage.

                                                     Rules of Participation CAIXAIMPULSE CONSOLIDATE   6
4.9. Projects under the CaixaImpulse Programme can apply to the Call as long as the
     Valorisation Plan of the Assets has been approved by the Programme Office before
     the application.

4.10. Projects that evaluate the efficacy or safety of products, therapies, medical devices,
      or diagnostic systems of for-profit organizations are not eligible for this Call.

Beneficiary
4.11. The Beneficiary is the entity that owns or co-owns the Assets and whose main
      activity must be located and registered in Spain or Portugal. The Beneficiary will
      be responsible for submitting the application form.

4.12. Beneficiaries must be public or non-profit organisations: including universities
      and university foundations, research centres, technological centres, hospitals, and
      hospital foundations.

4.13. Projects may be submitted by a consortium of legal entities from all EU Member
      States, as long as they are led and represented by the Beneficiary, which owns or
      co-owns the Assets. In case of a consortium, all stakeholders must abide by the
      eligibility criteria.

Linked Third Party
4.14. In case the Beneficiary had incorporated, or incorporates during the term of the
      Grant, a Spin-off Company, the Beneficiary may declare the Spin-off Company
      as a Linked Third Party for the execution of the Project. Such a declaration will be
      made upon application to the Call with regard to existing Spin-off Companies, or
      immediately after incorporation, for those incorporated during the Project (in these
      cases the Engagement Letter duly executed together with an explanation of the
      impact on the Full Proposal, if any, shall be submitted within one month from the
      notice of incorporation given to LCBF).

4.15. The representation of the Linked Third Party for the purposes of the Call will corre-
      spond to the Beneficiary. The Beneficiary must ensure that its obligations under the
      Call also apply to the Linked Third Party. The Beneficiary remains responsible to-
      wards LCBF for any activities carried out by the Linked Third Party under the Project.

4.16. The Linked Third Party may declare the costs it incurs for developing the Project,
      provided that any such costs fulfil -mutatis mutandis- the general and specific con-
      ditions for eligibility set out in sections 7.1 and 7.3. To prevent any doubt, mutatis
      mutandis means that (i) costs declared by the Linked Third Party would have to be
      eligible as if they were incurred by the Beneficiary itself and (ii) no cost inherent to
      the Spin-off Company’s activity and not derived specifically from the execution of
      the Project will be considered (e.g., company management and governance costs
      and salaries are not eligible; personnel costs are eligible if they are related to per-
      sonnel working for and assigned to the Project).

Project Leader
4.17. The Project Leader (PL) must be an individual with tertiary qualifications (university
      graduate, professor, or doctor).

4.18. The Project Leader is expected to commit to the development of the proposal by
      being dedicated primarily to the Project.

                                               Rules of Participation CAIXAIMPULSE CONSOLIDATE   7
4.19. The Project Leader may or may not be the leader of the research Project (i.e., Prin-
          cipal Investigator) that generated the Assets.

    4.20. The Project Leader may be involved in more than one application, but can be
          Project Leader in only one.

    4.21. The Project Leader will be provided with sufficient scientific and administrative sup-
          port by the Beneficiary to ensure the proper management and development of the
          Project. The Beneficiary will inform LCBF about the link with the Project Leader.

5   Application Process

    5.1. To initiate the submission process, Project Leaders will need to complete the online
         application forms available on the LCBF application platform (www.CaixaImpulse.
         com) and provide the required documentation. Incomplete applications or those
         presented on paper or via any other channel may be considered ineligible.

    5.2. Applications must be completed in English. LCBF reserves the right to request for
         the translation of official documents into English, when reasonably justified.

    5.3. To accelerate the proposal evaluation process, the application process will entail
         two steps: the initial submission of a Letter of Intent, and the subsequent submis-
         sion of a Full Proposal. Only pre-selected Projects will be invited to submit a Full
         Proposal.

    5.4. A template for the Letter of Intent will be available on the LCBF application platform.
         The following information and documentation will be requested:

        »» General information and Project description
        »» Team and Scientific and technical feasibility
        »» Transferability and market potential
        »» Social relevance and potential impact
        »» Letter from the Beneficiary informing about the link with the Project Leader and its
           commitment with regards to the Project.

    5.5. For pre-selected Projects invited to submit a Full Proposal in the electronic platform,
         the following additional documentation may be requested:

        »» Development stage of the project:
           »» Documentation on valorisation activities (PoC, prototypes, preclinical/clinical as-
              says, etc). Max. 5 pages.
           »» Reference/support letters from the TTO office of equivalent institution (if available).
           »» Project leaders’ CV (max 1 page).
           »» Business Plan (if available).
           »» Patent or IP strategy information.
           »» In case the Beneficiary had incorporated a Spin-off Company: the public deed of
              incorporation, the technology transfer agreement, a shareholders’ engagement

                                                    Rules of Participation CAIXAIMPULSE CONSOLIDATE   8
letter (including a statement on accepting the Spin-off Company to be declared
                as a Linked Third Party, if applicable) (the “Engagement Letter”), and any other
                document that may be deemed necessary for this purpose, upon specific request
                from LCBF (e.g., agreements signed with the Spin-off Company, the shareholders’
                agreement, an updated statement on the shareholders).
              »» Gantt chart (linked to proposed milestones).

          »» Compliance of the Beneficiary with the legal and regulatory requirements:
              »» Accreditation document.
              »» A certificate from the Tax Agency assuring that the applicant centre has fulfilled its
                 obligations with regards to taxation, valid at the moment of application.
              »» Social Security Certificate, valid at application date, assuring that the applicant
                 centre has fulfilled its obligations with regards to employment.
              »» Copy of the power of attorney certifying the capacity of the representative to act
                 on behalf of the Beneficiary.
              »» Acceptance letter1 duly signed (template provided).
              »» Certification of data validation2 (template provided).
              »» In case of consortia and/the participation of Linked Third Parties as provided un-
                 der 4.13 and 4.14, the distribution of the grant between the members of the con-
                 sortium (template provided) and/or the Spin-off.

6   Evaluation Process and Criteria

    The evaluation process is composed of two stages: pre-selection and selection. In each
    stage, eligibility checks will be conducted by the CaixaImpulse Programme Office. All
    pre-selected applications will be revised to ensure the fulfilment of the criteria pub-
    lished in these Rules for Participation. Any application that does not fulfil the criteria
    published in these Rules for Participation or that do not have the mandatory documents
    will be rejected, and notification will be sent to the applicant.

    Pre-selection process
    6.1. Eligible proposals will be assigned to be remotely reviewed by innovation experts
         (internal and external) in three main perspectives. Evaluators will be asked to review
         the overall quality and feasibility of the Projects, with an emphasis on ensuring the
         robustness of a specific area according to their expertise:

          »» Technology transfer: Projects need to present the relevance of the scientific con-
             cept underlying the Asset and provide a solid Assets’ development strategy within
             their business area.
          »» Financial attractiveness: Projects will need to ensure their financial feasibility and
             sustainability and present their market potential.
          »» Societal impact: Projects need to prove their social relevance in solving a specific
             societal need.

    1 This letter shall declare that all entities that co-own the Assets (including the Beneficiary and, when applicable, all
    stakeholders forming the Consortium) agree with these Rules for Participation and the appointment of the Beneficiary of
    the Programme as their representative.
    2 This letter shall declare that the Beneficiary entity certifies that the provided documents correspond to the original
    documentation of the Institution.

                                                                    Rules of Participation CAIXAIMPULSE CONSOLIDATE             9
6.2. Applicants will be notified as to whether or not their applications have been
     short-listed. Pre-selected Projects will be invited to submit a Full Proposal to the
     next phase of the call.

Selection process
6.3. Pre-selected applicants will be invited for a face-to-face interview with the Innova-
     tion Selection Board. The Innovation Selection Board will be composed of experts
     from different sectors of the innovation and biomedical ecosystem.

6.4. The evaluation will start when members of the Innovation Selection Board receive
     and review the full proposals. Evaluators can request further information or docu-
     mentation on the Projects through the CaixaImpulse Programme Office.

6.5. Candidates will be invited to Barcelona to present their Projects in a face-to-face
     interview. The interviews will be held in English.

6.6. In order to be evaluated, the Project Leader must attend the face-to-face interview
     and cannot delegate such participation to a team member.

6.7. The general aim of the interviews is to assess more precisely the quality, consisten-
     cy, and soundness of the Projects.

6.8. The Innovation Selection Board members will score the Projects between 1 (very
     poor) and 5 (exceptional) for each evaluated criterion. The evaluation criteria di-
     mensions are listed below:

    »» Team and Implementation feasibility (35%)
    »» Assets’ Development roadmap (30%)
    »» Assets’ Transfer potential (20%)
    »» Social impact and Responsible Innovation (15%).

6.9. Each Member of the Innovation Selection Board will score the proposals individu-
     ally. A ranking of the best proposals will be generated accordingly.

6.10. After interviewing all the candidates, the Innovation Selection Board will have the
      option to further discuss the quality and relevancy of proposals of the ranking and
      accordingly propose a final list of selected participants.

6.11. The LCBF Coordination Committee will be the body responsible for validating the
      final list of funded proposals.

6.12. All pre-selected applicants will be informed via email on whether or not the pro-
      posal was accepted for funding. Rejected proposals will receive an evaluation re-
      port to help applicants improve the quality of the Project submitted.

6.13. In case the proposal is improved upon and re-submitted, the Project will undergo
      the evaluation process under the same conditions as the rest of the proposals. After
      three unsuccessful attempts, LCBF reserves the right to discard the application to
      the corresponding three next cut-offs of the Call.

                                             Rules of Participation CAIXAIMPULSE CONSOLIDATE   10
7   Support to Projects

    CaixaImpulse Consolidate will offer the following resources to the selected Projects:

    Financial resources
    7.1. A grant of up to EUR 300,000 for 24 months (the “Grant”). LCBF may consider, by
         way of exception, a Grant amount above this limit, subject to availability of funds
         made available for the Call and the specific needs of the Project.

    7.2. The Grant may cover expenses such as:

        »» Technological development of the Asset.
        »» Consulting, feasibility, and market study services.
        »» Evaluation studies needed for regulatory approval.
        »» Hiring of personnel destined to the development of the Project.
        »» Management of intellectual property strategies.
        »» Overhead expenses up to a maximum of 10% of the total budget.
        »» Travel or representation expenses.

    7.3. Costs derived from concepts that are not directly related to the Project’s mile-
         stones or that do not directly contribute to the successful development of the
         Asset will not be accepted.

    7.4. Payments will be made in various instalments, in accordance with the payment
         plan defined for each Project. Selected Projects will sign an agreement with LCBF
         that will be prepared in collaboration with the Project Leader and that will define
         the payment, follow up, reporting, and reimbursement terms and conditions (the
         “Project Agreement”).

    7.5. A rigorous follow-up system will be implemented to assure the accomplishment of
         the valorisation actions and the achievement of proposed milestones. The financial
         support payments will be linked directly to this follow-up system.

    7.6. The funds pertaining to the Project will be transferred to the Beneficiary. In case
         of consortia and/or the participation of Linked Third Parties, the Beneficiary will be
         responsible for distributing the funds as specified in the Project Agreement.

    7.7. The Beneficiary will also be responsible for justifying the costs incurred by all con-
         sortium members and Linked Third Parties, as well as those costs derived from
         subcontracting, if applicable.

    Non-financial
    7.8. Each Project will be assigned a Project Manager from LCBF or selected third entity
         who will permanently and closely monitor the Project development.

    7.9. If requested by the Beneficiary, LCBF may assign a mentor to the Project for the first
         year in the Programme.

                                                  Rules of Participation CAIXAIMPULSE CONSOLIDATE   11
7.10. Additionally, each Project will have the possibility to rely on LCBF or an affiliated en-
          tity for additional non-financial support, which may include the following activities:

        »» Access to the CaixaImpulse experts’ network to receive support in specific aspects
           (IP, business administration, etc.).
        »» Training for specific valorisation and business abilities.
        »» Guide and support from a panel of experts involved in the CaixaImpulse Pro-
           gramme.
        »» Other justifiable actions will be considered upon request.

8   Follow-up of Projects

    The Project Agreement will set up the KPIs (key performance indicators), the payments
    and the frequency of the follow-up meetings. The specific needs of each Project will be
    taken into account when negotiating the agreement.

    8.1. Follow-up of Projects

        »» For any paperwork or consultation throughout the duration of the Grant, the Pro-
           ject Leader may contact the LCBF Project Manager (hereinafter “LCBF Project
           Manager”) or LCBF through the email address caixaimpulse@fundaciolacaixa.org.
        »» LCBF will provide a username and password to access the CaixaImpulse follow-up
           platform (www.fblcresearch.com). The details of the Grant awarded will be kept
           up-to-date, and any action carried out with the funding of the Grant awarded must
           be reported even after the period of validity for the funds of the grant has ended.
        »» The LCBF Project Manager will request that the Project Leader schedule regular
           follow-up meetings which include the prior submission of:
           »» An economic report. The incorrect justification of expenses might delay further
              financial support.
           »» A report on the achieved milestones detailed in the agreement signed between
              the Beneficiary and LCBF. Delays or alterations to the workplan will be carefully
              evaluated by the Project Manager and may impact the payment plan or lead to
              early termination of the Project Agreement in case of material and/or unjustified
              alterations.

    8.2. Key performance indicators (KPIs)

        »» Mid-term payments will be contingent upon the achievement of personalized KPIs
           and milestones that will be defined in detail in the agreement signed between the
           Beneficiary and LCBF.

                                                    Rules of Participation CAIXAIMPULSE CONSOLIDATE   12
B. General Annex
9   IP Rights, Protection and Maintenance of the Assets

    9.1. IP Rights

         Under no circumstances will the Call be construed as an assignment or transfer of
         any industrial and/or intellectual property right held or owned by the Beneficiary
         prior to the Project or of any other industrial and/or intellectual property right ob-
         tained as a result of the development of the Project.

         At the time of application to this Call and at least until the award of the Grant, all
         intellectual and/or industrial property rights over the Assets shall be owned by the
         Beneficiary and, where appropriate, the co-owner(s). To prevent any doubt, this
         requirement shall be deemed to be met in the case of a transfer of the assets by
         means of a license of use and exploitation to a Spin-off Company as referred to in
         above.

    9.2. Protection and maintenance of the Assets

         The Beneficiary and, where appropriate, the co-owner(s) of the Assets (or, if appro-
         priate, the licensor of the Assets) will make their best efforts to protect and maintain
         the Assets by taking on the following actions:

        »» Monitor the application proceedings for the grant of intellectual and industrial
           property rights, as well as keep and maintain the rights granted on the Assets within
           the necessary or recommended national authorities.
        »» In the event of the Assets not being suitable for protection under intellectual or
           industrial property rights, to keep the Assets under reasonable trade secret protec-
           tion measures.
        »» In the event of the Assets being transferred by means of a license, hold a subsidiary
           right for the defence and protection of the rights protecting the Assets, in case of
           inactivity of the licensee:
           »» if there is a breach or alleged breach of the rights protecting the Assets by third
              parties (the “Third Party Breach”); and/or
           »» when a third party has filed a claim for an alleged breach of a prior right (the “Third
              Party Claim”).

        »» Such right for defence and protection of the rights protecting the Assets shall con-
           sist of the following:

           »» to immediately inform the other parties of such Third-Party Breach or Third-Party
              Claim, identifying the known facts as well as the details of the individual or legal
              person that has committed said Third Party Breach or attaching a copy of the
              Third-Party Claim and identifying any other known facts;
           »» to request and subsequently deliver to LCBF, in due time and form, the relevant
              reports on the viability and appropriateness of (a) carrying out any legal actions,
              notices, legal proceedings, and/or any procedures that are applicable in the rele-
              vant jurisdiction in order to defend its interests, in the case of a Third Party Breach;

                                                    Rules of Participation CAIXAIMPULSE CONSOLIDATE   13
and (b) the legal actions to be taken in the relevant jurisdiction in order to defend
              its interests in the case of a Third Party Claim; and
            »» to take on, as the case may be, the organisation and management of the pro-
               ceedings and disburse any applicable costs and fees within the exercise of its
               rights in the case of the Third-Party Breach or its rights for the defence against
               the Third-Party Claim.

10   Exploitation

     10.1. The Beneficiary may exploit the Assets as follows:

         »» Direct exploitation: direct exploitation of the Assets by the Beneficiary; or
         »» Exploitation by transfer of the Assets to a third party or by means of a license of use
            and exploitation; or
         »» Exploitation by means of an incorporation of a Spin-off Company and the transfer
            of the Assets to such Spin-off Company by means of a license of use and exploita-
            tion.

     10.2. The exploitation of the Assets shall be made in market conditions and will ensure
           the adequate diffusion and social return.

     10.3. The Beneficiary will communicate in advance to LCBF the proposed terms and
           conditions for the exploitation of the Assets. LCBF will have the right to oppose
           such exploitation in the event it is not carried out in market conditions or the dis-
           semination and social return is not guaranteed through the exploitation.

11   Reimbursement

     In case one or more of the indicators established in these Rules for Participation are
     achieved, LCBF will be entitled to the reimbursement of the awarded Grant in accord-
     ance with the reimbursement procedure detailed below and subject to the specific
     term and conditions of the Project Agreement. The reimbursed money will be reinvest-
     ed in LCBF’s research and innovation programmes.

     11.1. Indicators

         »» Recurring Payment: Any payment obtained by the Beneficiary from the exploita-
            tion of the Assets by means of (i) direct exploitation by the Beneficiary; or (ii) roy-
            alties derived from exploitation by a Spin-off Company or a third-party licensee;
            or (iii) dividends obtained from the shares owned by the Beneficiary in the Spin-off
            Company. To prevent doubt, Recurring Payment excludes any Lump-sum pay-
            ment described in 11.2 below.
         »» Lump-sum payment: (i) The sale by the Beneficiary of the shares owned in Spin-off
            Company; or (ii) the assignment by the Beneficiary of the Asset resulting from the
            Project.

                                                   Rules of Participation CAIXAIMPULSE CONSOLIDATE   14
11.2. Reimbursement protocol

     The following payments will be due by Beneficiary to LCBF until the full reimbursement
     of the Grant in each of the cases described below. To prevent doubt, the amount to be
     reimbursed shall not accrue interest between the award of the Grant and the full reim-
     bursement.

         »» Recurring Payment: An amount equal to five per cent (5%) of any Recurring Pay-
            ment received by the Beneficiary as described in Section 11.1 above.
         »» Lump-sum payment for the sale of shares by the Beneficiary: the amounts defined
            below in the event of the sale of the Beneficiary’s shares in the Spin-off Company:
            »» If the sale price of the shares of the Beneficiary in the Spin-off Company is equal
               to or exceeds five (5) times the awarded Grant, the whole amount of the Grant
               shall be reimbursed to LCBF.
            »» If the sale price of the shares of the Beneficiary in the Spin-off Company is less
               than five (5) times the awarded Grant, the Beneficiary will reimburse the amount
               of the Grant in proportion to the ratio between the sale price of the shares of the
               Beneficiary and five (5) times the awarded Grant.
            »» The reimbursement shall be paid in one instalment within two (2) years from the
               sale of the shares of the Beneficiary.
         »» Lump-sum payment for the transfer of the Asset by the Beneficiary: The Benefi-
            ciary will reimburse to LCBF any lump-sum payment for the transfer of the Asset(s)
            up to the whole amount of the Grant, less any payment made by the Beneficiary as
            a result of any recurring payment or sale of shares as referred to above.
            »» The reimbursement shall be paid in one instalment within two (2) years from the
               transfer of the Asset by the Beneficiary.
         »» Alternatively, and at LCBF’s choice, the amount due as reimbursement of the Grant
            may be capitalized by LCBF in shares of the Spin-off Company.

     In the event that the exploitation of the Asset(s) did not occur under any of the
     above-mentioned models, the parties will do their best efforts to agree on an equiva-
     lent reimbursement protocol.

     11.3. Reimbursement term

     LCBF’s right to the reimbursement of the awarded Grant as provided above will termi-
     nate after twenty (20) years from the signing of the Project Agreement provided that,
     if the reimbursement had started during the last four (4) years of the referred term, the
     right will continue in force for an additional term of five (5) years from the first reim-
     bursement.

12   Subscription Right

     12.1. If the exploitation of the Assets is to be carried out by means of a Spin-off Com-
           pany as provided in 10.3 above, LCBF or any entity within the Criteria Group, at
           the discretion of the Criteria Group, shall have the right to subscribe shares of the
           Spin-off Company, in accordance with the following:

                                                   Rules of Participation CAIXAIMPULSE CONSOLIDATE   15
»» If the Spin-off Company (i) had not been incorporated at the time of the applica-
            tion to the Call or (ii) had been incorporated, but had not been transferred the As-
            sets as of the time of the application to the Call, up to 1% of the shares, at nominal
            value, within one (1) month from the signing of the Project Agreement.
         »» In any other case, up to 1% of the shares of the Company (i) at the post-money
            valuation of the last financing round or (ii) in the absence of any financing round,
            at nominal value, within one (1) month from the signing of the Project Agreement.

     12.2. The Beneficiary shall ensure that the Spin-off Company and its shareholders are
           first aware of, and expressly accept, the rights granted to LCBF or any entity within
           the Criteria Group in accordance to the foregoing and adhere, where applicable, to
           the obligations derived from these Rules for Participation, which shall be included
           in the terms of the Engagement Letter as described in 5.5 above. This provision shall
           also be deemed to apply to the reimbursement described in Clause 11 above, where
           applicable.

13   Other Obligations

     13.1. Obligations of the Beneficiary

     Within the framework of the Call, the Beneficiary will abide by the following obligations,
     without prejudice to any other obligations set forth in these Rules for Participation:

         »» Sign the Project Agreement.
         »» Exploit the Assets in market conditions. In case the exploitation of the Assets is not
            carried out in market conditions, LCBF will have a right to veto such exploitation.
         »» Refrain from entering into any agreements and/or undertaking any exploitations
            of the Assets and/or taking any other actions or inactions which may hinder or
            prevent the compliance with these Rules for Participation by the Beneficiary, the
            Co-Owner(s) of the Assets (if applicable), and their successors and assignees, in-
            cluding, but not limited to, any actions or inactions which would be incompatible
            with honouring LCBF’s reimbursement rights and LCBF’s participation rights.
         »» Keep LCBF informed about any exploitation of the Assets and provide LCBF with
            any information and documentation needed so as to enable LCBF to exercise its
            reimbursement rights and/or monitor the reimbursement, including, but not limit-
            ed to, a copy of the Assets’ transfer agreements entered into with third parties and
            any accounting and supporting documents which may be reasonably requested
            by LCBF for the aforementioned purpose (e.g., account books, details on royalties
            or other payments made by transferees, turnover and net sales information, etc.).
         »» Keep LCBF informed in case the exploitation of the Assets is to be carried out by
            a Spin-off Company or a third-party and provide LCBF with any information and
            documentation needed so as to enable LCBF to exercise its rights to reimburse-
            ment as provided in Section 11 above.
         »» For a period of five (5) years after the date on which the final report is due, keep and
            make available to LCBF all original documentation which may be required to jus-
            tify the expenses incurred. During this period, LCBF reserves the right to conduct
            random financial audits to the Projects.

                                                    Rules of Participation CAIXAIMPULSE CONSOLIDATE   16
»» Use the entire amount of the Grant to develop the Project, in accordance with
            these Rules for Participation.
         »» Manage the Project with due diligence, monitor the task carried out by the Project
            Leader and his/her team, and inform LCBF on the progress and results achieved by
            the Project.
         »» Observe and comply with the justification of expenses submitted within the exe-
            cution of the Project.
         »» Assume the social and ethical implications of the Project in accordance with the
            research personnel’s ethical code, also taking into account the gender dimension.
         »» Indicate the support received from the CaixaImpulse Programme through mate-
            rials, publications, and dissemination activities developed within the framework of
            the Project.
         »» Prepare regular financial and milestones reports reflecting the development of the
            Project and attend an annual follow-up meeting with its LCBF Project manager.
         »» After the execution of the Project, deliver the final report to LCBF.
         »» Provide any information that LCBF may require in order to promote, publish, and/or
            disseminate the CaixaImpulse Programme, in particular those transactions that, as
            a result of their nature, may be subject to coverage by the media, and consequent-
            ly give coverage to the Beneficiaries’ results and/or the results achieved by any of
            its participants, e.g., research and development activities, marketing, transaction
            and turnover results, securing investments, whether through their own resources
            (share capital or reserves) or transfer of shares, participations, securities, or rights to
            purchase and subscribe shares, participations, or securities, etc. Without prejudice
            to the foregoing, the information provided as a result of the obligation described
            herein may be treated as confidential upon express request from the Beneficiary.

     13.2. Obligations of the Project Leader

     Within the framework of the Call, the Project Leader will abide by the following obliga-
     tions, without prejudice to any other obligations set forth in these Rules for Participation:

         »» Respect and comply with all obligations and duties pursuant to these Rules for
            Participation.
         »» Use the entire amount of the grant to execute the Project, always in accordance
            with these Rules for Participation.

14   Representations and Warranties

     14.1. The Beneficiary represents and warrants that it is an entity that has been incorpo-
          rated and lawfully exists in accordance with the laws of Spain and Portugal and is
          duly authorised to apply for this Call and carry out the obligations set out in these
          Rules for Participation.

     14.2. The Beneficiary and the Project Leader represent and warrant that:

         »» these Rules for Participation are legal and valid obligations which bind them and
            are enforceable in all of their terms and conditions.

                                                     Rules of Participation CAIXAIMPULSE CONSOLIDATE   17
»» the application, execution, and compliance with these Rules for Participation do
            not contravene any contract, documents, or agreements, verbal or written, to
            which they are party or to which they are bound, nor do they infringe upon any
            laws or regulations of any courts, governmental or administrative entities, or any
            other body that may have jurisdiction over them.

15   Breach and Liability

     15.1. Breach

         »» In the event of a remediable breach by the Beneficiary and/or the Project Leader
            of the obligations and/or representations and warranties contained in these Rules
            for Participation, LCBF shall notify the breaching party, requesting that the latter
            correct the infringement within a maximum period of thirty (30) days following the
            receipt of such notification.
         »» If after the aforementioned 30-day period no remedy had been provided, LCBF
            will be entitled to choose between demanding forced compliance or terminating
            these Rules for Participation, and LCBF will have the right, in both cases, to claim
            for the corresponding compensation for the damages caused by the infringement.
         »» Notwithstanding the foregoing, if LCBF resolved that the Beneficiary had not used
            the Grant in accordance with the specified purposes provided in these Rules for
            Participation, the Beneficiary shall be obliged to return the Grant in full, without
            prejudice to compensation for damages to which LCBF could be entitled. Like-
            wise, if the justification of expenses of the Project were less than the amount of the
            Grant awarded, the Beneficiary shall be obligated to reimburse the amount corre-
            sponding to the part of the Grant not justified.

     15.2. Liability

     The Beneficiary and the Project Leader will hold LCBF and any entity of the Criteria Group
     harmless in relation to any costs, damages, and/or expenses (including reasonable legal
     fees) that may result from the breach or defective compliance of their obligations under
     these Rules for Participation. Notwithstanding the above, the Beneficiary will be solely
     responsible before the Project Leader and LCBF and CCR for any costs, damages, and/or
     expenses (including reasonable legal fees) resulting from the breach of the Beneficiary’s
     obligation to use the amount of the Grant.

16   Duration

     16.1. The rights and obligations set out in these Rules for Participation shall start on the
           date the Beneficiary accepts and adheres thereto, which shall be formalised through
           the execution of the Acceptance Letter (the “Effective Date”).

                                                   Rules of Participation CAIXAIMPULSE CONSOLIDATE   18
16.2. The rights and obligations set out in these Rules for Participation shall terminate
           once any of the following events occur:

         »» Mutual written agreement between LCBF and the Beneficiary.
         »» Failure to comply with the duties regarding protection and maintenance of the
            Assets, as provided in Section 9 above, effective upon LCBF’s notice of non-com-
            pliance, which may be remedied within the time frame provided upon LCBF’s dis-
            cretion.
         »» Reimbursement of the Grant to LCBF, when applicable.
         »» Sufficient evidence, to the entire satisfaction of LCBF, of the following:
            »» failure to implement the Project within the 3-year term granted to that end, un-
               less such failure is attributable to the Beneficiary, in which case Section 15.1 of
               these Rules for Participation shall apply; and/or
            »» failure to implement the Project, including, without limitation, the exploitation
               of the Assets, unless such failure is attributable to the Beneficiary, in which case
               Section 15.1 of these Annexes to the Rules for Participation shall apply.
     16.3. Without prejudice to the above, the following sections shall be valid for twenty-five
           (25) years following the termination of the Rules for Participation: 9.1 (Intellectu-
           al and industrial property rights), 9.2 (Protection and maintenance of the Assets),
           10 (Exploitation), 11 (Reimbursement), 17 (Confidentiality), 18 (Data Protection), 19
           (Publicity and Dissemination) and 20 (Miscellaneous).

17   Confidentiality

     17.1. The confidentiality of the applications presented is guaranteed throughout the en-
           tire process. In any case, the general characteristics of the applications may be dis-
           seminated and, in due course, the name of accepted Projects (and logo, if applica-
           ble), a brief description, the Beneficiary and its logo, the name of the Project Leader
           and his/her photo, may be published through, without limitation, press releases,
           emails, brochures, and websites to communicate information about the Call.

     17.2. The information content and the results of the Project, as well as any other infor-
           mation and documentation exchanged within the framework (including informa-
           tion and documentation regarding other Project participants) of the Call shall be
           considered confidential information (the “Confidential Information”).

     17.3. LCBF, the Beneficiary, and the Project Leader, as well as any other person attending
           the activities, shall undertake, unless prior authorisation in writing is received from
           the other parties, to:

         »» keep the Confidential Information strictly confidential and not to disclose it to any
            Third Parties;
         »» not use the Confidential Information for any purpose other than the development
            of the Project;
         »» restrict access to the Confidential Information exclusively to those employees, col-
            laborators, and/or professional advisers that, under the obligation of confidentiali-
            ty, need to access the Confidential Information strictly for the development of the
            Project; and

                                                   Rules of Participation CAIXAIMPULSE CONSOLIDATE   19
»» return the Confidential Information without keeping any copies or summaries
            when the Programme is terminated.

     17.4. The confidentiality obligations described in the section above shall not be applied
           to the Confidential Information if:

         »» the information is in the public domain before or at the moment at which it is re-
            ceived or obtained, and it is in the public domain by no fault or negligence of the
            receiving party;
         »» the information is obtained without being subject to any confidentiality obligation;
            and
         »» the disclosure of the information is required by law or judicial order, in which case
            said disclosure request must be previously notified, in advance, to the other party,
            so that the latter can implement the actions it considers necessary to prevent or
            limit the disclosure.

     17.5. The obligations and commitments set in this section shall extend to information to
           which the Parties have had access as a result of their participation in the activities and
           events carried out within the framework of the Call, including, but not limited to, the
           activities and events offered under LCBF mentoring and expert advice programmes.

18   Data Protection

     18.1. The applicants authorize LCBF to access, use, and share information from the Pro-
           jects submitted to the Call, including any and all documents referred to therein,
           whether submitted at the time of the application or at a later stage, for the purposes
           of this Call and to the extent necessary, including, but not limited to, the evaluation,
           selection, and monitoring of the Projects. The applicants warrant to LCBF that such
           information and documentation can be shared and used for these purposes.

     18.2. With regards to identifying and/or professional information of individuals linked to
           the Projects (including the Project Leader, other team members, and representatives),
           the applicant organizations, when submitting the Proposals, warrant having informed
           those persons on the information indicated in the sub-section below and, where ap-
           plicable, having obtained the necessary consent of those persons for their inclusion in
           the applications submitted to this call. Any and all personal data collected within the
           framework of this Call (including data submitted in the applications) will be processed
           for the purpose of managing the participation of the applicant organizations in it, the
           basis of such processing being the performance of the resulting relationship, and
           such data will be stored until the end of the applicable statutory limitation periods.

     18.3. Personal data will be communicated only if needed to comply with legal obli-
           gations. LCBF hires service providers located outside of the European Economic
           Space, with all guarantees required by applicable regulations. The data subjects
           can ask for more information and/or exercise their rights of access, rectification,
           erasure, restriction, portability, and objection before the Data Protection Officer of
           the “la Caixa” Foundation at Avinguda Diagonal 621–629, 08028 Barcelona, Spain,
           or at the e-mail address dpd@fundacionlacaixa.org. Data subjects are also entitled
           to lodge a complaint before the Spanish Data Protection Agency.

                                                     Rules of Participation CAIXAIMPULSE CONSOLIDATE   20
19   Publicity and Dissemination

     19.1. Publicity

     LCBF will be entitled to disclose the results of the Beneficiary’s Project where relevant, in
     international, national, and/or regional media considered to be the most suitable and on
     all those platforms where examples of excellence and good practice in the area of inno-
     vation are required. For this purpose, the general characteristics of the applications may
     be disseminated and, in due course, the name of the accepted Project, a brief description,
     the Beneficiary, and the name of the Project Leader may be published through, without
     limitation, press releases, emails, brochures, and websites. To prevent doubt, LCBF will
     not be required in any case to pay any compensation to Beneficiaries for the dissemina-
     tion and publication of the results of the Projects.

     19.2. Dissemination

     The Beneficiary shall promote the maximum dissemination of the Grant, subject to a pre-
     vious agreement with the LCBF through the LCBF Project Manager:

         »» The Project Leader and the Beneficiary shall, in due course, provide LCBF with in-
            formation regarding communication and dissemination actions, materials, events,
            and activities that they develop in relation to the Project during their participation
            in the Call, so that they may be duly notified and/or represented and can request
            changes and/or approve of brands and logotypes.
         »» The responsible party shall make reference to the Grant awarded by LCBF (refer-
            ence, CODE, and logo whenever possible) in any actions, results and communi-
            cation and dissemination materials which are carried out in relation to the Project
            and the Grant (e.g., e-mails, letters, brochures, posters, advertisements, graphic
            material, pamphlets, apps, social networks, publications, reports, patents, licens-
            es, scientific articles, etc.) and also in any acts and activities which are organised
            or in which the winner participates in relation with the Project (e.g., workshops,
            courses, interviews, press releases, Project, and/or results presentations, scientific
            congresses, etc. and all support material).
         »» The correct reference is “The project leading to these results has received fund-
            ing and support from the “la Caixa” Foundation under CaixaImpulse Grant <
            code reference>”. LCBF will provide the specific code reference for each Project.
         »» The LCBF’s online channels to link to or mention are:
            »» Twitter: @FundlaCaixa and/or @CaixaCiencia (https://twitter.com/CaixaCiencia,
               https://twitter.com/FundlaCaixa )
            »» Instagram: @fundlacaixa
            »» Facebook: @obrasociallacaixa
            »» LinkedIn: Fundación Bancaria “la Caixa”
         »» The LCBF websites are:
            »» https://obrasociallacaixa.org/es/investigacion-y-becas/
            »» www.CaixaImpulse.com
         »» Any dissemination of the results of the Project shall indicate that such dissemina-
            tion only reflects the author’s view and that LCBF is not responsible for any use that
            may be made of the information that it contains.

                                                   Rules of Participation CAIXAIMPULSE CONSOLIDATE   21
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